Healthy
Conditions
Brief summary
This is a Phase 1, randomized, parallel-cohort, open-label study to characterize the pharmacokinetics, pharmacodynamics, safety and tolerability of vupanorsen following 80 mg and 160 mg single subcutaneous dose in healthy Chinese adults with elevated fasting triglyceride.
Interventions
DRUGVupanorsen
80 mg subcutaneous injection
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male and female Chinese participants must be 18 to 65 years of age, inclusive, at the time of signing the ICD. * Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants. * Chinese participant is defined as individuals currently residing in mainland China who were born in China and have both parents of Chinese descent. 2. Male and female Chinese participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests (except for TG levels), and 12-lead ECG monitoring. 3. Fasting TG ≥ 90 mg/dL at Screening (up to 1 repeat allowed for TG and the second TG value will be used for the eligibility). 4. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. 5. BMI of 17.5 to 35.0 kg/m2; and a total body weight \>50 kg (110 lb). 6. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
Exclusion criteria
1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). 2. History of human immunodeficiency virus (HIV) infection, syphilis, hepatitis B, or hepatitis C; positive testing for HIV, syphilis, HBsAg, or HCVAb. Prior Hepatitis B vaccination is allowed. 3. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. 4. Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention. 5. Previous administration with an investigational drug within 4 months or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). 6. A positive urine drug test. 7. Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest. If BP is ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility. 8. Baseline 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline QTc interval \>450 msec, complete LBBB, signs of an acute or indeterminate-age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second- or third-degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline uncorrected QT interval is \>450 msec, this interval should be rate-corrected using the Fridericia method and the resulting QTcF should be used for decision making and reporting. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the participant's eligibility. Computer-interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding participants. 9. Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary: * AST or ALT level ≥1.25 × ULN; * Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is≤ ULN. 10. History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit or 3 ounces (90 mL) of wine). 11. Blood donation (excluding plasma donations) of approximately 400 mL or more within 60 days prior to dosing. 12. History of sensitivity to heparin or heparin-induced thrombocytopenia. 13. History of substance abuse within 12 months of the screening visit. 14. Pregnant females; breastfeeding females. 15. Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol. 16. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC24h) for Vupanorsen | 0 hour (predose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on day 1 | AUC24h is the area under the concentration-time profile from time 0 to 24 hour post-dose |
| AUC From Time 0 to 48 Hours Post-dose (AUC48h) for Vupanorsen | 0 hour (predose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours post dose | AUC48h is the area under the plasma concentration-time profile from time zero to the quantifiable concentration 48 hours post-dose |
| AUC From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) for Vupanorsen | 0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90 | AUClast is the area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast) |
| Maximum Observed Concentration (Cmax) | 0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90 | Maximum plasma concentration observed from data |
| AUC From Time 0 Extrapolated to Infinite Time (AUCinf) for Vupanorsen | 0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90 | AUCinf is area under the plasma concentration-time profile from time zero extrapolated to infinite time |
| Time for Cmax (Tmax) for Vupanorsen | 0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90 | Time for Cmax (Tmax) for vupanorsen |
| Terminal Elimination Half Life (t½) for Vupanorsen | 0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90 | terminal elimination half life (t½) for vupanorsen |
| Apparent Clearance (CL/F) for Vupanorsen | 0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90 | Apparent clearance for vupanorsen |
| Apparent Volume of Distribution (Vz/F) for Vupanorsen | 0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90 | Apparent volume of distribution for vupanorsen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Changes From Baseline in Angiopoietin-Like 3 (ANGPTL3) | Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 | Percent changes from baseline in ANGPTL3 on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 |
| Percent Change From Baseline in Total Cholesterol | Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 | Percentage changes from baseline in total cholesterol on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 |
| Percent Change From Baseline in Apolipoprotein A-1 (ApoA-I) | Day 1, Day 15, Day 60, and Day 90 | Percentage changes from baseline in ApoA-I on Day 15, Day 60, and Day 90. This endpoint was terminated due to changes of development plan. |
| Percent Change From Baseline in Apolipoprotein B (ApoB) Total (Including ApoB-48, ApoB-100) | Day 1, Day 15, Day 60, and Day 90 | Percentage changes from baseline in ApoB total (including ApoB-48, ApoB-100) on Day 15, Day 60, and Day 90. This endpoint was terminated due to changes of development plan. |
| Percent Change From Baseline in Apolipoprotein C-III (ApoC-III) | Day 1, Day 15, Day 60, and Day 90 | Percentage changes from baseline in apolipoprotein C-III (ApoC-III) on Day 15, Day 60, and Day 90. This endpoint was terminated due to changes of development plan. |
| Percent Changs From Baseline in High-density Lipoprotein Cholesterol (HDL-C) | Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 | Percentage changes from baseline in HDL-C on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 |
| Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 | Percentage changes from baseline in non-HDL on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 |
| Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 | Percentage changes from baseline in LDL-C on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 |
| Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) | Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 | Percentage changes from baseline in VLDL-C on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 |
| Percent Change From Baseline in Triglyceride | Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 | Percentage changes from baseline in triglyceride on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Baseline through day 90 | Adverse events (AEs): any untoward medical occurrence in a clinical investigation participant administered a product or medical device, without regard to causality. Treatment-emergent AEs (TEAEs): AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. AEs included SAEs and non-serious AEs. Treatment-related TEAEs were any untoward medical occurrence attributed to study treatment. Causality to study treatment was determined by the investigator. |
| Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) | Baseline through day 90 | Protocol-required safety laboratory assessments included chemistry, hematology, and urinalysis (and microscopy, if needed). Each parameter was evaluated against commonly used and widely accepted criteria. |
| Number of Participants With Clinically Significant Vital Sign Values | Baseline through day 90 | Vital sign data included blood pressure and pulse rate. Clinical significance was assessed by the investigator. |
| Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Values | Baseline through day 90 | Clinical significance of ECG data was assessed by the investigator. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vupanorsen 80 mg Participants were selected and categorized into the Vupanorsen 80 mg group and received a single 80 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90. | 9 |
| Vupanorsen 160 mg Participants were selected and categorized into the Vupanorsen 160 mg group and received a single 160 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90. | 9 |
| Total | 18 |
Baseline characteristics
| Characteristic | Vupanorsen 160 mg | Total | Vupanorsen 80 mg |
|---|---|---|---|
| Age, Continuous | 36.22 Years STANDARD_DEVIATION 8.45 | 33.83 Years STANDARD_DEVIATION 7.97 | 31.44 Years STANDARD_DEVIATION 7.13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 18 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 18 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Male | 8 Participants | 15 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 3 / 9 | 5 / 9 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 |
Outcome results
Primary
Apparent Clearance (CL/F) for Vupanorsen
Apparent clearance for vupanorsen
Time frame: 0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90
Population: The analysis population refers to all participants enrolled and treated who had at least 1 of the vupanorsen PK parameters of primary interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Vupanorsen 80 mg | Apparent Clearance (CL/F) for Vupanorsen | 19.60 liter per hour (L/hr) | Geometric Coefficient of Variation 36 |
| Vupanorsen 160 mg | Apparent Clearance (CL/F) for Vupanorsen | 13.43 liter per hour (L/hr) | Geometric Coefficient of Variation 39 |
Primary
Apparent Volume of Distribution (Vz/F) for Vupanorsen
Apparent volume of distribution for vupanorsen
Time frame: 0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90
Population: The analysis population refers to all participants enrolled and treated who had at least 1 of the vupanorsen PK parameters of primary interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Vupanorsen 80 mg | Apparent Volume of Distribution (Vz/F) for Vupanorsen | 12500 liter (L) | Geometric Coefficient of Variation 37 |
| Vupanorsen 160 mg | Apparent Volume of Distribution (Vz/F) for Vupanorsen | 8681 liter (L) | Geometric Coefficient of Variation 48 |
Primary
Area Under the Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC24h) for Vupanorsen
AUC24h is the area under the concentration-time profile from time 0 to 24 hour post-dose
Time frame: 0 hour (predose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on day 1
Population: The analysis population refers to all participants enrolled and treated who had at least 1 of the vupanorsen pharmacokinetic (PK) parameters of primary interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Vupanorsen 80 mg | Area Under the Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC24h) for Vupanorsen | 3.649 microgram*hour per milliliter(mcg*hr/mL) | Geometric Coefficient of Variation 35 |
| Vupanorsen 160 mg | Area Under the Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC24h) for Vupanorsen | 10.82 microgram*hour per milliliter(mcg*hr/mL) | Geometric Coefficient of Variation 42 |
Primary
AUC From Time 0 Extrapolated to Infinite Time (AUCinf) for Vupanorsen
AUCinf is area under the plasma concentration-time profile from time zero extrapolated to infinite time
Time frame: 0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90
Population: The analysis population refers to all participants enrolled and treated who had at least 1 of the vupanorsen PK parameters of primary interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Vupanorsen 80 mg | AUC From Time 0 Extrapolated to Infinite Time (AUCinf) for Vupanorsen | 4.081 mcg*hr/mL | Geometric Coefficient of Variation 36 |
| Vupanorsen 160 mg | AUC From Time 0 Extrapolated to Infinite Time (AUCinf) for Vupanorsen | 11.91 mcg*hr/mL | Geometric Coefficient of Variation 39 |
Primary
AUC From Time 0 to 48 Hours Post-dose (AUC48h) for Vupanorsen
AUC48h is the area under the plasma concentration-time profile from time zero to the quantifiable concentration 48 hours post-dose
Time frame: 0 hour (predose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours post dose
Population: The analysis population refers to all participants enrolled and treated who had at least 1 of the vupanorsen PK parameters of primary interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Vupanorsen 80 mg | AUC From Time 0 to 48 Hours Post-dose (AUC48h) for Vupanorsen | 3.699 mcg*hr/mL | Geometric Coefficient of Variation 34 |
| Vupanorsen 160 mg | AUC From Time 0 to 48 Hours Post-dose (AUC48h) for Vupanorsen | 10.91 mcg*hr/mL | Geometric Coefficient of Variation 42 |
Primary
AUC From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) for Vupanorsen
AUClast is the area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast)
Time frame: 0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90
Population: The analysis population refers to all participants enrolled and treated who had at least 1 of the vupanorsen PK parameters of primary interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Vupanorsen 80 mg | AUC From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) for Vupanorsen | 3.950 mcg*hr/mL | Geometric Coefficient of Variation 34 |
| Vupanorsen 160 mg | AUC From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) for Vupanorsen | 11.76 mcg*hr/mL | Geometric Coefficient of Variation 39 |
Primary
Maximum Observed Concentration (Cmax)
Maximum plasma concentration observed from data
Time frame: 0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90
Population: The analysis population refers to all participants enrolled and treated who had at least 1 of the vupanorsen PK parameters of primary interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Vupanorsen 80 mg | Maximum Observed Concentration (Cmax) | 0.5879 microgram per milliliter (μg/mL) | Geometric Coefficient of Variation 62 |
| Vupanorsen 160 mg | Maximum Observed Concentration (Cmax) | 1.810 microgram per milliliter (μg/mL) | Geometric Coefficient of Variation 63 |
Primary
Terminal Elimination Half Life (t½) for Vupanorsen
terminal elimination half life (t½) for vupanorsen
Time frame: 0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90
Population: The analysis population refers to all participants enrolled and treated who had at least 1 of the vupanorsen PK parameters of primary interest.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vupanorsen 80 mg | Terminal Elimination Half Life (t½) for Vupanorsen | 475.9 hour (hr) | Standard Deviation 205.5 |
| Vupanorsen 160 mg | Terminal Elimination Half Life (t½) for Vupanorsen | 465.2 hour (hr) | Standard Deviation 131.5 |
Primary
Time for Cmax (Tmax) for Vupanorsen
Time for Cmax (Tmax) for vupanorsen
Time frame: 0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90
Population: The analysis population refers to all participants enrolled and treated who had at least 1 of the vupanorsen PK parameters of primary interest.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vupanorsen 80 mg | Time for Cmax (Tmax) for Vupanorsen | 2.00 hour (hr) |
| Vupanorsen 160 mg | Time for Cmax (Tmax) for Vupanorsen | 2.00 hour (hr) |
Secondary
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Values
Clinical significance of ECG data was assessed by the investigator.
Time frame: Baseline through day 90
Population: All participants enrolled and who took at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vupanorsen 80 mg | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Values | 0 Participants |
| Vupanorsen 160 mg | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Values | 0 Participants |
Secondary
Number of Participants With Clinically Significant Vital Sign Values
Vital sign data included blood pressure and pulse rate. Clinical significance was assessed by the investigator.
Time frame: Baseline through day 90
Population: All participants enrolled and who took at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vupanorsen 80 mg | Number of Participants With Clinically Significant Vital Sign Values | 1 Participants |
| Vupanorsen 160 mg | Number of Participants With Clinically Significant Vital Sign Values | 0 Participants |
Secondary
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Protocol-required safety laboratory assessments included chemistry, hematology, and urinalysis (and microscopy, if needed). Each parameter was evaluated against commonly used and widely accepted criteria.
Time frame: Baseline through day 90
Population: All participants enrolled and who took at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vupanorsen 80 mg | Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) | 5 Participants |
| Vupanorsen 160 mg | Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) | 5 Participants |
Secondary
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Adverse events (AEs): any untoward medical occurrence in a clinical investigation participant administered a product or medical device, without regard to causality. Treatment-emergent AEs (TEAEs): AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. AEs included SAEs and non-serious AEs. Treatment-related TEAEs were any untoward medical occurrence attributed to study treatment. Causality to study treatment was determined by the investigator.
Time frame: Baseline through day 90
Population: All participants enrolled and who took at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vupanorsen 80 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | All-causality | 3 Participants |
| Vupanorsen 80 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment-related | 2 Participants |
| Vupanorsen 160 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | All-causality | 5 Participants |
| Vupanorsen 160 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment-related | 1 Participants |
Secondary
Percent Change From Baseline in Apolipoprotein A-1 (ApoA-I)
Percentage changes from baseline in ApoA-I on Day 15, Day 60, and Day 90. This endpoint was terminated due to changes of development plan.
Time frame: Day 1, Day 15, Day 60, and Day 90
Population: Study endpoint of percent changes from baseline in apolipoprotein A-1 (ApoA-I),apolipoprotein B (ApoB) total (including ApoB-48, ApoB-100), and apolipoprotein C-III (ApoC-III) on Day 15, Day 60, and Day 90, were terminated due to changes of development plan. No data were collected for these terminated endpoints.
Secondary
Percent Change From Baseline in Apolipoprotein B (ApoB) Total (Including ApoB-48, ApoB-100)
Percentage changes from baseline in ApoB total (including ApoB-48, ApoB-100) on Day 15, Day 60, and Day 90. This endpoint was terminated due to changes of development plan.
Time frame: Day 1, Day 15, Day 60, and Day 90
Population: Study endpoint of percent changes from baseline in apolipoprotein A-1 (ApoA-I),apolipoprotein B (ApoB) total (including ApoB-48, ApoB-100), and apolipoprotein C-III (ApoC-III) on Day 15, Day 60, and Day 90, were terminated due to changes of development plan. No data were collected for these terminated endpoints.
Secondary
Percent Change From Baseline in Apolipoprotein C-III (ApoC-III)
Percentage changes from baseline in apolipoprotein C-III (ApoC-III) on Day 15, Day 60, and Day 90. This endpoint was terminated due to changes of development plan.
Time frame: Day 1, Day 15, Day 60, and Day 90
Population: Study endpoint of percent changes from baseline in apolipoprotein A-1 (ApoA-I),apolipoprotein B (ApoB) total (including ApoB-48, ApoB-100), and apolipoprotein C-III (ApoC-III) on Day 15, Day 60, and Day 90, were terminated due to changes of development plan. No data were collected for these terminated endpoints.
Secondary
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Percentage changes from baseline in LDL-C on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90
Time frame: Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90
Population: All participants enrolled and treated who had at least 1 of the PD parameters of interest.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vupanorsen 80 mg | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | DAY60 | -12.77 percent change (%) | Standard Deviation 23.668 |
| Vupanorsen 80 mg | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | DAY90 | -7.42 percent change (%) | Standard Deviation 19.649 |
| Vupanorsen 80 mg | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | DAY2 | 2.94 percent change (%) | Standard Deviation 9.247 |
| Vupanorsen 80 mg | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | DAY3 | 1.91 percent change (%) | Standard Deviation 12.944 |
| Vupanorsen 80 mg | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | DAY8 | -14.65 percent change (%) | Standard Deviation 9.005 |
| Vupanorsen 80 mg | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | DAY15 | -14.95 percent change (%) | Standard Deviation 19.076 |
| Vupanorsen 80 mg | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | DAY30 | -9.86 percent change (%) | Standard Deviation 22.385 |
| Vupanorsen 160 mg | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | DAY90 | 2.97 percent change (%) | Standard Deviation 10.818 |
| Vupanorsen 160 mg | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | DAY60 | 0.19 percent change (%) | Standard Deviation 15.38 |
| Vupanorsen 160 mg | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | DAY8 | -12.10 percent change (%) | Standard Deviation 15.647 |
| Vupanorsen 160 mg | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | DAY30 | -6.03 percent change (%) | Standard Deviation 16.71 |
| Vupanorsen 160 mg | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | DAY2 | -0.63 percent change (%) | Standard Deviation 7.817 |
| Vupanorsen 160 mg | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | DAY15 | -15.93 percent change (%) | Standard Deviation 16.486 |
| Vupanorsen 160 mg | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | DAY3 | 2.80 percent change (%) | Standard Deviation 11.548 |
Secondary
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Percentage changes from baseline in non-HDL on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90
Time frame: Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90
Population: All participants enrolled and treated who had at least 1 of the PD parameters of interest.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vupanorsen 80 mg | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | DAY8 | -22.58 percent change (%) | Standard Deviation 8.362 |
| Vupanorsen 80 mg | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | DAY30 | -15.33 percent change (%) | Standard Deviation 16.925 |
| Vupanorsen 80 mg | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | DAY3 | -0.12 percent change (%) | Standard Deviation 12.865 |
| Vupanorsen 80 mg | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | DAY60 | -11.58 percent change (%) | Standard Deviation 22.194 |
| Vupanorsen 80 mg | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | DAY15 | -23.18 percent change (%) | Standard Deviation 15.173 |
| Vupanorsen 80 mg | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | DAY90 | -8.32 percent change (%) | Standard Deviation 16.806 |
| Vupanorsen 80 mg | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | DAY2 | -1.39 percent change (%) | Standard Deviation 7.609 |
| Vupanorsen 160 mg | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | DAY90 | -6.35 percent change (%) | Standard Deviation 7.602 |
| Vupanorsen 160 mg | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | DAY2 | -2.40 percent change (%) | Standard Deviation 6.649 |
| Vupanorsen 160 mg | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | DAY3 | -0.89 percent change (%) | Standard Deviation 9.12 |
| Vupanorsen 160 mg | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | DAY8 | -23.41 percent change (%) | Standard Deviation 8.368 |
| Vupanorsen 160 mg | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | DAY15 | -25.37 percent change (%) | Standard Deviation 11.202 |
| Vupanorsen 160 mg | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | DAY30 | -15.58 percent change (%) | Standard Deviation 10.089 |
| Vupanorsen 160 mg | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | DAY60 | -3.89 percent change (%) | Standard Deviation 9.669 |
Secondary
Percent Change From Baseline in Total Cholesterol
Percentage changes from baseline in total cholesterol on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90
Time frame: Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90
Population: All participants enrolled and treated who had at least 1 of the PD parameters of interest.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vupanorsen 80 mg | Percent Change From Baseline in Total Cholesterol | DAY8 | -18.89 percent change (%) | Standard Deviation 6.814 |
| Vupanorsen 80 mg | Percent Change From Baseline in Total Cholesterol | DAY30 | -10.46 percent change (%) | Standard Deviation 14.303 |
| Vupanorsen 80 mg | Percent Change From Baseline in Total Cholesterol | DAY3 | -1.71 percent change (%) | Standard Deviation 9.012 |
| Vupanorsen 80 mg | Percent Change From Baseline in Total Cholesterol | DAY60 | -8.26 percent change (%) | Standard Deviation 16.712 |
| Vupanorsen 80 mg | Percent Change From Baseline in Total Cholesterol | DAY15 | -19.57 percent change (%) | Standard Deviation 12.554 |
| Vupanorsen 80 mg | Percent Change From Baseline in Total Cholesterol | DAY90 | -5.10 percent change (%) | Standard Deviation 14.122 |
| Vupanorsen 80 mg | Percent Change From Baseline in Total Cholesterol | DAY2 | -1.50 percent change (%) | Standard Deviation 5.839 |
| Vupanorsen 160 mg | Percent Change From Baseline in Total Cholesterol | DAY90 | -3.06 percent change (%) | Standard Deviation 7.317 |
| Vupanorsen 160 mg | Percent Change From Baseline in Total Cholesterol | DAY2 | -2.04 percent change (%) | Standard Deviation 6.238 |
| Vupanorsen 160 mg | Percent Change From Baseline in Total Cholesterol | DAY3 | -0.71 percent change (%) | Standard Deviation 7.665 |
| Vupanorsen 160 mg | Percent Change From Baseline in Total Cholesterol | DAY8 | -20.39 percent change (%) | Standard Deviation 8.526 |
| Vupanorsen 160 mg | Percent Change From Baseline in Total Cholesterol | DAY15 | -21.85 percent change (%) | Standard Deviation 11.371 |
| Vupanorsen 160 mg | Percent Change From Baseline in Total Cholesterol | DAY30 | -11.11 percent change (%) | Standard Deviation 7.976 |
| Vupanorsen 160 mg | Percent Change From Baseline in Total Cholesterol | DAY60 | -1.76 percent change (%) | Standard Deviation 10.038 |
Secondary
Percent Change From Baseline in Triglyceride
Percentage changes from baseline in triglyceride on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90
Time frame: Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90
Population: All participants enrolled and treated who had at least 1 of the PD parameters of interest.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vupanorsen 80 mg | Percent Change From Baseline in Triglyceride | DAY8 | -32.61 percent change (%) | Standard Deviation 16.422 |
| Vupanorsen 80 mg | Percent Change From Baseline in Triglyceride | DAY30 | -28.54 percent change (%) | Standard Deviation 20.289 |
| Vupanorsen 80 mg | Percent Change From Baseline in Triglyceride | DAY3 | -10.03 percent change (%) | Standard Deviation 16.856 |
| Vupanorsen 80 mg | Percent Change From Baseline in Triglyceride | DAY60 | -19.55 percent change (%) | Standard Deviation 29.981 |
| Vupanorsen 80 mg | Percent Change From Baseline in Triglyceride | DAY15 | -41.91 percent change (%) | Standard Deviation 19.992 |
| Vupanorsen 80 mg | Percent Change From Baseline in Triglyceride | DAY90 | 7.26 percent change (%) | Standard Deviation 59.83 |
| Vupanorsen 80 mg | Percent Change From Baseline in Triglyceride | DAY2 | -9.72 percent change (%) | Standard Deviation 15.235 |
| Vupanorsen 160 mg | Percent Change From Baseline in Triglyceride | DAY90 | -21.26 percent change (%) | Standard Deviation 28.335 |
| Vupanorsen 160 mg | Percent Change From Baseline in Triglyceride | DAY2 | -5.86 percent change (%) | Standard Deviation 12.887 |
| Vupanorsen 160 mg | Percent Change From Baseline in Triglyceride | DAY3 | -7.24 percent change (%) | Standard Deviation 26.804 |
| Vupanorsen 160 mg | Percent Change From Baseline in Triglyceride | DAY8 | -52.47 percent change (%) | Standard Deviation 18.15 |
| Vupanorsen 160 mg | Percent Change From Baseline in Triglyceride | DAY15 | -48.19 percent change (%) | Standard Deviation 16.491 |
| Vupanorsen 160 mg | Percent Change From Baseline in Triglyceride | DAY30 | -44.14 percent change (%) | Standard Deviation 19.466 |
| Vupanorsen 160 mg | Percent Change From Baseline in Triglyceride | DAY60 | -30.60 percent change (%) | Standard Deviation 23.585 |
Secondary
Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C)
Percentage changes from baseline in VLDL-C on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90
Time frame: Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90
Population: All participants enrolled and treated who had at least 1 of the PD parameters of interest.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vupanorsen 80 mg | Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) | DAY8 | -65.66 percent change (%) | Standard Deviation 19.581 |
| Vupanorsen 80 mg | Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) | DAY30 | -27.64 percent change (%) | Standard Deviation 40.099 |
| Vupanorsen 80 mg | Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) | DAY3 | 5.68 percent change (%) | Standard Deviation 35.419 |
| Vupanorsen 80 mg | Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) | DAY60 | 11.09 percent change (%) | Standard Deviation 50.942 |
| Vupanorsen 80 mg | Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) | DAY15 | -62.44 percent change (%) | Standard Deviation 27.207 |
| Vupanorsen 80 mg | Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) | DAY90 | -22.63 percent change (%) | Standard Deviation 58.405 |
| Vupanorsen 80 mg | Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) | DAY2 | -15.93 percent change (%) | Standard Deviation 18.32 |
| Vupanorsen 160 mg | Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) | DAY90 | -51.39 percent change (%) | Standard Deviation 37.174 |
| Vupanorsen 160 mg | Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) | DAY2 | -1.16 percent change (%) | Standard Deviation 28.947 |
| Vupanorsen 160 mg | Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) | DAY3 | -4.79 percent change (%) | Standard Deviation 45.277 |
| Vupanorsen 160 mg | Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) | DAY8 | -72.26 percent change (%) | Standard Deviation 21.036 |
| Vupanorsen 160 mg | Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) | DAY15 | -64.24 percent change (%) | Standard Deviation 31.482 |
| Vupanorsen 160 mg | Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) | DAY30 | -53.51 percent change (%) | Standard Deviation 27.018 |
| Vupanorsen 160 mg | Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) | DAY60 | 8.28 percent change (%) | Standard Deviation 77.143 |
Secondary
Percent Changes From Baseline in Angiopoietin-Like 3 (ANGPTL3)
Percent changes from baseline in ANGPTL3 on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90
Time frame: Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90
Population: All participants enrolled and treated who had at least 1 of the pharmacodynamic (PD) parameters of interest.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vupanorsen 80 mg | Percent Changes From Baseline in Angiopoietin-Like 3 (ANGPTL3) | DAY8 | -59.65 percent change (%) | Standard Deviation 18.727 |
| Vupanorsen 80 mg | Percent Changes From Baseline in Angiopoietin-Like 3 (ANGPTL3) | DAY30 | -48.66 percent change (%) | Standard Deviation 21.921 |
| Vupanorsen 80 mg | Percent Changes From Baseline in Angiopoietin-Like 3 (ANGPTL3) | DAY3 | -32.65 percent change (%) | Standard Deviation 22.375 |
| Vupanorsen 80 mg | Percent Changes From Baseline in Angiopoietin-Like 3 (ANGPTL3) | DAY60 | -38.54 percent change (%) | Standard Deviation 23.44 |
| Vupanorsen 80 mg | Percent Changes From Baseline in Angiopoietin-Like 3 (ANGPTL3) | DAY15 | -54.07 percent change (%) | Standard Deviation 21.893 |
| Vupanorsen 80 mg | Percent Changes From Baseline in Angiopoietin-Like 3 (ANGPTL3) | DAY90 | -12.69 percent change (%) | Standard Deviation 20.238 |
| Vupanorsen 80 mg | Percent Changes From Baseline in Angiopoietin-Like 3 (ANGPTL3) | DAY2 | -13.88 percent change (%) | Standard Deviation 18.644 |
| Vupanorsen 160 mg | Percent Changes From Baseline in Angiopoietin-Like 3 (ANGPTL3) | DAY90 | -29.72 percent change (%) | Standard Deviation 15.587 |
| Vupanorsen 160 mg | Percent Changes From Baseline in Angiopoietin-Like 3 (ANGPTL3) | DAY2 | -22.14 percent change (%) | Standard Deviation 15.103 |
| Vupanorsen 160 mg | Percent Changes From Baseline in Angiopoietin-Like 3 (ANGPTL3) | DAY3 | -43.56 percent change (%) | Standard Deviation 15.151 |
| Vupanorsen 160 mg | Percent Changes From Baseline in Angiopoietin-Like 3 (ANGPTL3) | DAY8 | -69.11 percent change (%) | Standard Deviation 13.462 |
| Vupanorsen 160 mg | Percent Changes From Baseline in Angiopoietin-Like 3 (ANGPTL3) | DAY15 | -69.48 percent change (%) | Standard Deviation 11.659 |
| Vupanorsen 160 mg | Percent Changes From Baseline in Angiopoietin-Like 3 (ANGPTL3) | DAY30 | -62.81 percent change (%) | Standard Deviation 18.873 |
| Vupanorsen 160 mg | Percent Changes From Baseline in Angiopoietin-Like 3 (ANGPTL3) | DAY60 | -53.33 percent change (%) | Standard Deviation 11.83 |
Secondary
Percent Changs From Baseline in High-density Lipoprotein Cholesterol (HDL-C)
Percentage changes from baseline in HDL-C on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90
Time frame: Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90
Population: All participants enrolled and treated who had at least 1 of the PD parameters of interest.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vupanorsen 80 mg | Percent Changs From Baseline in High-density Lipoprotein Cholesterol (HDL-C) | DAY8 | -3.97 percent change (%) | Standard Deviation 13.335 |
| Vupanorsen 80 mg | Percent Changs From Baseline in High-density Lipoprotein Cholesterol (HDL-C) | DAY30 | 8.96 percent change (%) | Standard Deviation 18.824 |
| Vupanorsen 80 mg | Percent Changs From Baseline in High-density Lipoprotein Cholesterol (HDL-C) | DAY3 | -3.81 percent change (%) | Standard Deviation 2.908 |
| Vupanorsen 80 mg | Percent Changs From Baseline in High-density Lipoprotein Cholesterol (HDL-C) | DAY60 | 8.19 percent change (%) | Standard Deviation 13.457 |
| Vupanorsen 80 mg | Percent Changs From Baseline in High-density Lipoprotein Cholesterol (HDL-C) | DAY15 | -3.33 percent change (%) | Standard Deviation 20.205 |
| Vupanorsen 80 mg | Percent Changs From Baseline in High-density Lipoprotein Cholesterol (HDL-C) | DAY90 | 6.74 percent change (%) | Standard Deviation 14.464 |
| Vupanorsen 80 mg | Percent Changs From Baseline in High-density Lipoprotein Cholesterol (HDL-C) | DAY2 | -0.55 percent change (%) | Standard Deviation 3.636 |
| Vupanorsen 160 mg | Percent Changs From Baseline in High-density Lipoprotein Cholesterol (HDL-C) | DAY90 | 5.92 percent change (%) | Standard Deviation 12.033 |
| Vupanorsen 160 mg | Percent Changs From Baseline in High-density Lipoprotein Cholesterol (HDL-C) | DAY2 | -0.79 percent change (%) | Standard Deviation 8.504 |
| Vupanorsen 160 mg | Percent Changs From Baseline in High-density Lipoprotein Cholesterol (HDL-C) | DAY3 | -0.14 percent change (%) | Standard Deviation 9.771 |
| Vupanorsen 160 mg | Percent Changs From Baseline in High-density Lipoprotein Cholesterol (HDL-C) | DAY8 | -9.16 percent change (%) | Standard Deviation 16.834 |
| Vupanorsen 160 mg | Percent Changs From Baseline in High-density Lipoprotein Cholesterol (HDL-C) | DAY15 | -10.08 percent change (%) | Standard Deviation 16.485 |
| Vupanorsen 160 mg | Percent Changs From Baseline in High-density Lipoprotein Cholesterol (HDL-C) | DAY30 | 3.70 percent change (%) | Standard Deviation 15.475 |
| Vupanorsen 160 mg | Percent Changs From Baseline in High-density Lipoprotein Cholesterol (HDL-C) | DAY60 | 5.18 percent change (%) | Standard Deviation 15.265 |